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510(k) Data Aggregation
K Number
K980357Device Name
KONAN NONCON ROBO PACHY SPECULAR MICROSCOPE AND OPTICL PACHYMETER
Manufacturer
KONAN, INC.
Date Cleared
1998-04-24
(85 days)
Product Code
HKI, NOE
Regulation Number
886.1120Why did this record match?
Applicant Name (Manufacturer) :
KONAN, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Konan Noncon Robo Pachy is a specular microscope and optical pachymeter, manufactured by Konan Inc. It is a noncontact ophthalmic microscope and ccamera intended for examination of the corneal endothelium, with the additional capability of measuring the corneal thickness by optical reans. Cell counting and analysis programs are included, and are indicated when it is desired to analyze the images of the cell distribution of the eye.
Device Description
The Noncon Robo Pachy specular microscope and optical pachymeter is a non-contact ophthalmic microscope, optical pachymeter, and camera intended for examination of the corneal endothelium and for measurement of the thickness of the cornea. It is an improvement to the original Konan Noncon Robo, K950091.
The device permits visual inspection and photography of corneal endothelium and measurement of the corneal the thickness without any object contacting the eye. It features focusing by means of infrared techniques, and computer-assisted cell counting and cell analysis capabilities. The computer functions are also used to aid in setting up the various features of the machine and to aid in photography. Photographic images are temporarily stored in the system's memory, and are preserved in video form on magnetic tape or by using a video printer. The memory can store two endothelial cell images and two anterior segment images, which are usually those of the left and right eyes.
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